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In studies on VESIcare and pregnancy, the medication caused certain problems when it was given to pregnant mice. It appeared to reduce survival, cause low fetal weight, and increase the risk of a cleft palate in fetuses that were exposed to the drug. If you are taking VESIcare and pregnancy occurs, your healthcare provider will weigh the benefits and risks in your particular situation.
VESIcare® (solifenacin succinate) is a prescription medicine used to treat symptoms of an overactive bladder. It may not be safe for use in pregnant women. In animal studies, the drug caused problems when used during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant mice, VESIcare caused low fetal weight and increased the risk of a cleft palate. Newborn mice that were exposed to the drug were less likely to survive. Giving VESIcare to pregnant rabbits did not appear to cause any problems. No studies have evaluated the drug in pregnant women.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits for the woman outweigh any possible risks to the unborn child.